Palbociclib in Metastatic Breast Cancer: Gene Polymorphism-based Study in Egyptian Patients.

Launched by HELWAN UNIVERSITY · Mar 24, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Palbociclib for women with a specific type of advanced breast cancer known as hormone receptor-positive and HER2-negative metastatic breast cancer. The aim is to see how well this treatment works for patients who have already tried other therapies and may not have had success with them. The trial will focus on Egyptian women between the ages of 65 to 74 who meet certain health criteria, such as having a confirmed diagnosis of metastatic breast cancer and being able to participate safely.

To be eligible for the trial, participants need to be adults (18 years or older) with hormone receptor-positive, HER2-negative breast cancer that has spread. They should have already experienced some resistance to previous hormone treatments and be in good overall health, as measured by a specific performance scale. However, women who have previously been treated with certain medications or who have serious health issues related to their cancer won’t be able to join. Those who participate can expect to receive Palbociclib as part of their treatment plan and will be closely monitored throughout the trial. This study is not currently recruiting participants, so you would need to wait until it begins.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Adult patients (≥18 years). 2. Confirmed diagnosis with MBC. 3. HR-positive/HER2-negative MBC as ascertained by immunohistochemistry (IHC) or fluorescence in situ hybridization in primary or metastatic tissue samples.
• • 4. Patients with primary or secondary resistance to endocrine therapy. 5. Patients with Eastern Cooperative Oncology Group (ECOG) 0 or 1. 6. Scheduled to receive Palbociclib in first- or second-line metastatic setting.
• Exclusion Criteria:
• • 1. Prior exposure to fulvestrant or everolimus.
• • 2. Patients with uncontrolled brain metastases or symptomatic visceral spread who are at risk of life-threatening complications.
• • 3. Patients refusing to sign the written informed consent.